Epidermal Cells Delivery and Acute Burns

Phase 3

Terminated

• Conditions: Burn
• Interventions: Device: autologous epidermal cells harvesting kits; Procedure: classic skin grafts

• Registration Number: NCT00774033
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The aim of the study is to compare results obtained with epidermal cell spray and classic skin grafting for epidermal replacement in acute burns

Detailed Description

Comparing the impact in terms of cicatrisation duration and costs between 2 treatments of deep 2nd and 3rd degree burns.

Determine if the costs of the innovating treatment RECELL®, a priori more expensive, are counterbalanced by a shorter cicatrisation duration and an improved evolution versus a conventional strategy.

Give an information about efficiency improvement of RECELL® with additional costs

Study Timeline

• Study First Submitted: 2008-10-15
• Study First Submitted QC: 2008-10-15
• Study First Posted: 2008-10-16
• Study Start: 2008-12
• Primary Completion: 2012-02
• Status Verified: 2012-03
• Study Completion: 2012-05
• Last Update Submitted: 2012-07-25
• Last Update Posted: 2012-07-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Thermal burns requiring surgical debridement
• Area involved < 1260cm²

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Exclusion Criteria

• local or systemic infection
• conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
• hypersensitivity to trypsin

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	autologous epidermal cells harvesting kits	Treatment of acute burn in adults and children by epidermal cell spray
2	classic skin grafts	Treatment of acute burn in adults and children by classic skin grafts

Primary Outcome Measures

Name	Time	Method
80% epithelialisation (recipient + owner sites) at one week. Percent epithelialisation at 1, 2 and 6 weeks.	at 1, 2 and 6 weeks

Secondary Outcome Measures

Name	Time	Method
Medical costs at complete epithelialisation	At 6, 12 and 18 months
Post-operative pain	At 6 weeks
Medical assessment of scar quality	at 6 weeks and 6, 12, 18 months
Patient self assessment of scar	At 6, 12 and 18 months

Trial Locations

Locations (1)

Hopital Trousseau; 🇫🇷 Paris, France